AccessGUDID - DEVICE: TroClear (B606TC10SPD1)

GUDID

Device Identifier (DI) Information

Brand Name: TroClear
Version or Model: TC10SPD
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TC10SPD
Company Name: Mednium Corporation

Primary DI Number: B606TC10SPD1
Issuing Agency: HIBCC
Commercial Distribution End Date: September 11, 2047
Device Count: 1
Labeler D-U-N-S® Number*: 080614210 *Terms of Use

Device Description: Hospital SPD trocar squeegee cleaning system is a non-sterile multiple use per IFU medical device. TroClear SPD TM cleans debris inside the trocar canula, TroClear TM SPD squeegees the canula clean in a single pass. TroClear TM SPD can be rinsed clean and reused multiple times per IFU.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
34878	Surgical instrument/endoscope cleaning utensil, reusable	A non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNL	Accessories, Cleaning Brushes, For Endoscope

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5c537c0b-87d4-4b8b-9a05-42499fca65c6
Public Version Date: October 16, 2024
Public Version Number: 2
DI Record Publish Date: September 12, 2024